The subject matter discussed in the background section should not be assumed to be prior art merely as a result of its mention in the background section. Similarly, a problem and the understanding of the causes of a problem mentioned in the background section should not be assumed to have been previously recognized in the prior art. The subject matter in the background section may merely represents different approaches, which in and of themselves may also be inventions.
Kawasaki disease (KD) is a pediatric disease causing inflammation of blood vessels. Although KD has been reported in all racial and ethnic groups, children of Asia-Pacific descent are primarily affected by this disease.
The earliest and most obvious symptom of KD is fever for at least five days. If left untreated, it leads to coronary artery aneurysms in approximately 20-25 percent of affected children and KD is the leading cause of acquired heart disease in young children in developed countries. The successful detection of KD within the first 10 days of fever onset followed by high dose intravenous immunoglobulin (IVIG) can greatly reduce the incidence of coronary artery lesion.
There is currently no definitive laboratory diagnostic test for KD and the diagnosis of KD is largely a clinical one, based on the American Heart Association (AHA) 2004 diagnostic criteria. These diagnosis criteria include fever over 5 days, bilateral nonsuppurative conjunctivitis, changes to the mucous membranes, indurative angioedema of the hands and feet, dysmorphous skin rashes and acute nonpurulent cervical lymphadenopathy >1.5 cm in diameter.
However, the AHA criteria is slightly different from that of Japan Circulation Society guideline, which makes the clinical diagnosis of KD perplexing. In addition, infectious diseases, such as staphylococcal or streptococcal infection, may mimic KD. It can be difficult for the clinicians to accurately diagnose KD and promptly administer IVIG to prevent coronary artery disease in the affected children.
There is an unmet need for an economical and accurate laboratory diagnostic test for KD and the present invention satisfy this and other needs.